Events

Retiro De Equipo (Recall) de Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Biomet Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00910-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-26
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00910-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Zimmer biomet has discovered a raw material anomaly during an inspection of various trauma and extremity instruments (drill bits, screw taps and saw blades). an investigation by the supplier determined that four lots of raw material could have similar anomalies. the anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. the affected units were distributed between the dates of march 2016 and may 2017.This issue may lead to extension of surgery < 30 minutes and/or the patient retains piece of fractured instrument leading to patient injury.This issue is not visually detectable in all cases. one injury has been reported internationally.
  • Acción
    Zimmer Biomet is conducting a lot specific recall for various trauma and extremity instruments (drill bits, screw taps and saw blades). Hospital Responsibilities: 1.Review this notification and ensure affected personnel are aware of the contents; 2.Assist the Zimmer Biomet sales representative quarantine all affected product; 3.The Zimmer Biomet sales representative will remove the affected product from your facility; 4.Complete the supplied Attachment 1 – Certificate of Acknowledgement; a.Return a digital copy to RAQA.ANZ@zimmerbiomet.com b.Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.

Device

Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)
  • Modelo / Serial
    Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)Multiple Item and Lot NumbersARTG Numbers: 112735 and 209302
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA